Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

NCT02882672 | Completed Phase 1 DMC

• 1 other identifier: 201527898IR
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could improve adiponectin and cardiovascular disease risk factors in overweight coronary heart disease patients. Patients were included in the study if: they were approved to do so following a physical, physiological and psychological test; did not take part in regular physical activity; had stable heart failure for at least 3 months. Exclusion criteria included: a history of surgery within the preceding 4 months; had an unstable angina, acute phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease; exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health problems that prevented maximum effort on the treadmill test. Target population included of all patients with a history of myocardial infarction and diagnosis of congestive heart failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary heart disease patients were randomly assigned to either an eight-week, three times weekly exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging, flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.

Conditions

Exercise; Cardiac Myosins; Patients

Outcome Measures

Primary Outcomes (2)

• Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method

  Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes.

  up to 8 weeks

• Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method

  up to 8 weeks

Secondary Outcomes (2)

• Effect of Exercise-based cardiac rehabilitation on weight was measured

  up to 8 weks

• Effect of Exercise-based cardiac rehabilitation on height was measured

  up to 8 weks

Study Arms (2)

Experimental

EXPERIMENTAL

experimental group did 8 weeks exercise training

Other: Experimental

Control

EXPERIMENTAL

Control group did not do any exercise training.

Other: Control

Interventions

Experimental OTHER

Doing exercise at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging

Experimental

Control OTHER

They did not do ant exercise training during 8 weeks.

Control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• they were approved to do so following a physical, physiological and psychological test; resided and worked in the city of Isfahan; did not take part in regular physical activity; had stable heart failure for at least 3 months.

You may not qualify if:

• a history of surgery within the preceding 4 months
• had an unstable angina, acute phase of myocardial infarction (MI), and/or unstable arrhythmia
• had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury (mmHg), aortic stenosis, and/or peripheral artery disease
• exercise limitations due to neuromuscular and/or musculoskeletal disease, such as any type of orthopedic, low back pain, bone fracture of less than 6 months
• uncontrolled systemic disease, such as DM; were 75 years or older
• had any health problems that prevented maximum effort on the treadmill test
• unable to answer the screening questionnaires assessing depression and anxiety.

Sponsors & Collaborators

• University of Isfahan: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Mehdi Kargarfard

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 30, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share